NCL offers support for Increasing Access to Biosimilars Act (S. 1427)

December 16, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242

Washington, DC—The National Consumers League (NCL) is pleased to support the Increasing Access to Biosimilars Act (S. 1427), as introduced by Senators Michael Bennet (D-CO) and John Cornyn (R-TX). This Act directs the U.S. Department of Health and Human Services (HHS) to launch a pilot program that increases Medicare payments for providers who use biosimilars. Representative Tony Cárdenas (D-CA) introduced a similar bill (H.R. 2869) in the House of Representatives.

Since 2014, the growth in pharmaceutical spending has been primarily driven by increased spending on biologic drugs. Biosimilars demonstrate no clinically meaningful differences in terms of safety, purity, and potency against their FDA-approved biologic counterpart, and are generally 15 percent to 35 percent lower in price. Therefore, biosimilars pose great potential to reduce health care costs.

The Increasing Access to Biosimilars Act would create a new pilot program administered by the Center for Medicare & Medicaid Innovation (CMMI) that aims to encourage physicians to prescribe less expensive biosimilars through shared savings. Shared savings is a payment strategy that offers providers a percentage of any net savings generated in order to reduce health care spending overall.

The following statement can be attributed to NCL’s Health Policy Director Jeanette Contreras:

“This legislation would not only broaden access to cost-saving biosimilars and reduce unnecessary spending on costly biologics, but it could also foster greater competition. In addition, it signals to future participants the viability of the biosimilars market, which is a win for consumers.

NCL believes that well-aligned payment incentives can steer providers toward cost-saving behavior with the overall objective of reducing Medicare expenditures. We strongly urge Congress to pass the Increasing Access to Biosimilars Act as the FDA continues to approve new biosimilars to market at increasing rates.”

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Abortion: The continuous fight for reproductive freedoms

By NCL Health Policy Intern Grace Mills

Grace Mills is a DC native, completing her undergraduate education at American University in Washington, DC. Her major is Public Health, with a minor in Spanish language. She will graduate in May 2022.

Women in the United States have been fighting for reproductive rights for decades. Activists like Margaret Sanger and Mary Ware Dennett argued during the early part of the 20th Century that women must be in control of their reproductive choices; the book “The Birth of the Pill” documents their crusade. Officials tried to prevent these two and many others from speaking and publishing about human sexuality, reproduction, and contraception. In the succeeding decades, activists pioneered the right to contraception, the right to abortion, and the right to bear a child.

Several landmark cases are worthy of mention. In Griswold v. Connecticut (1965), the Supreme Court ruled that a state’s ban on the use of contraceptives violated the right to marital privacy. In 1971, in the case of United States v. Vuitch, the Court rejected the claim that a statute permitting abortion only to preserve a woman’s life or health was unconstitutionally vague. It concluded that “health” should be understood to include considerations of psychological as well as physical well-being. The following year, in Eisenstadt v. Baird, the Supreme Court struck down a Massachusetts law limiting the distribution of contraceptives to married couples whose physicians had prescribed them. This decision established the right of unmarried individuals to obtain contraceptives.

In 1973, Roe v. Wade was a challenge to a Texas law prohibiting all but lifesaving abortions. The Supreme Court invalidated the law on the ground that the constitutional right to privacy encompasses a woman’s decision whether or not to terminate her pregnancy. Characterizing this right as “fundamental” to a woman’s “life and future,” the Court held that the state could not interfere with the abortion decision unless it had a compelling reason for regulation. NCL strongly supports the landmark protections in this case, including a woman’s right to control her own reproductive destiny.

Sadly, Roe v. Wade has been under attack from the right since 1973. After the Trump Administration’s Supreme Court appointments, there is a 6-member majority that appears to favor overturning Roe vs. Wade. States will have the right to pass far more restrictive laws than what Roe allowed for constitutionally. There will always be states that protect women’s right to choose and access to abortion, however, the issues lies in women living in states with restrictive laws or lack of money and/or resources to get to an abortion clinic.

This flies in the face of what the public wants. Indeed, a recent Gallup poll show Americans’ support for abortion in all or most cases at 80 percent in May, only slightly higher than in 1975 (76 percent), and the Pew Research Center finds 59 percent of adults believe abortion should be legal, compared to 60 percent in 1995. The share of Americans in Gallup’s poll who say abortion is morally acceptable reached a record high of 47 percent in May, up from a low of 36 percent in 2009, and a Quinnipiac poll found support for abortion being legal in all or most cases reached a near-record high in September with 63 percent support.

Many red states have recently passed some of the most restrictive and punitive abortion laws. In March of 2018, former governor of Mississippi Phil Bryant, signed into law the strictest abortion ban in the country up until that point. The law bans abortion at 15 weeks (about 3 and a half months), even in cases of rape or incest. But a federal district court judge shut the law down, and the U.S. Court of Appeals for the Fifth Circuit backed the court’s decision. This law is what was challenged in the Supreme Court last week.

Perhaps the most extreme is S.B. 8, the Texas law that went into effect on September 1, 2021 that prohibits abortion after “cardiac activity is detectable,” which is usually around the 6-week mark (about 1 and a half months). The law has a vigilante justice component, letting Texans sue anyone they believe is violating the law and/or is involved in an abortion in some way. This includes anyone who provides transportation to the abortion (even an Uber driver could be culpable) or a physician that performs the abortion after 6 weeks. This is the most draconian legislation so far, in part because many women do not even know they are pregnant at just 6 weeks.

S.B. 8 specifically does not allow state officials to enforce the law, authorizing only private citizens to do so, by suing an abortion provider for damages of ten thousand dollars for each procedure performed — what several Justices referred to, during oral arguments on November 1st, as a “bounty.” The Supreme Court will likely have the chance to review a challenge to the constitutionality of this law, but that’s a few years away and until then, the law remains in force.

NCL strongly supports women’s access to reproductive, abortion and maternal care. We understand that lack of access is directly related to a wide range of health disparities in the United States. It is no surprise that people of color in the United States have less access to the care they need and have more health complications. This is true for reproductive care and family planning. Black and Hispanic women have much higher abortion rates than white women largely directly related to a higher rate of unintended pregnancy.

These facts raise the question about what more can be done to provide women of color better maternal care and family planning resources. We need to reverse the pattern of inequality. NCL supports funding for sex education, full access to maternal care, and family planning to provide women with services, information and resources necessary to make informed decisions about their reproductive health and prevent any unnecessary health risks.

The tenuous hold we have on the right to abortion in every state, with the Mississippi law likely to get the thumbs up from the anti-choice Supreme Court, puts all women at risk. The Texas law is that much more draconian. We lament these attacks on women’s access to health care — especially poor women — that these restrictive abortion laws represent. Lastly, making abortions a crime won’t stop them from happening, it will only drive abortion back into the back alley and make it once again, a dangerous procedure that puts women’s health and safety at risk.

Jeanette Contreras portrait

Listen up: FDA’s proposed OTC hearing aid rule

By NCL Director of Health Policy Jeanette Contreras

Whether it be listening to your grandchildren share a story or having dinner with a friend, many consumers rely on devices to help them hear and understand speech every day. Hearing loss is something that we need to be mindful of at all ages, and as consumers, we look to our nation’s regulators to make sure these devices are safe to use.

Some people with hearing loss are able to work closely with hearing care professionals to finely adjust their hearing aids at sound levels that enable them to hear speech at comfortable levels without causing any harm. But, as more Americans struggle with their hearing, accessible hearing aids becomes increasingly important. Proposed regulations by the Food and Drug Administration will allow hearing aids to be sold over-the-counter to adults with mild-to-moderate hearing loss, a step forward in making them more affordable and accessible.

While these regulations are positive for access, the FDA’s proposed thresholds for volume or output for over-the-counter hearing devices are more in line with those for earbuds people use to listen to music for short periods than they are for hearing aids that are worn for several hours a day. These draft rules would allow a maximum sound output level of between 115 and 120 dBA, which is the equivalent to the volume of a chain saw. According to the CDC, exposure of sounds at 120 dB could become dangerous in as little as nine seconds. As you can imagine, being exposed to this level of sound for long periods of time is unsafe and could increase hearing loss and significantly damage the ear.

Hence, there is widespread concern among hearing care professionals that allowing an unnecessarily high level of amplification can lead to further hearing loss. Leading hearing care associations recommend a maximum output limit of 110 dBA for OTC hearing aids and establishing a gain limit of 25 dB.

As the leading consumer healthcare organization, we applaud the FDA’s efforts to increase access to hearing aids for those who need them. We do hope that the FDA will adjust its proposal, so it is in line with the recommendations of hearing care professionals before finalizing the regulations. Consumers shouldn’t be concerned that they may find their situation worsened by devices that are intended to help.

To learn more about gain and output and how to protect yourself from hearing loss, check out our new infographic.

The drug pricing middlemen driving up drug costs

Healthcare continues to be front and center in the national discourse, particularly in the midst of the pandemic. As Congress works on policy solutions to lower healthcare costs for consumers, we face an unfair disadvantage when it comes to what we’re paying at the pharmacy counter.

Vaccines to protect all

 

By Sally Greenberg, NCL Executive Director
With co-author Marla Dalton, Executive Director and CEO, National Foundation for Infectious Diseases

COVID-19 has had profound implications on individual health and well-being and the U.S. healthcare system at-large. During the pandemic, we have seen routine vaccination rates decline significantly across all populations, putting individuals at risk of contracting vaccine-preventable diseases. The pandemic has also brought significant public attention to vaccines and now, perhaps more than ever before, many see the value of life-saving vaccines as one of the most effective public health prevention tools available to keep us safe and help end the pandemic.

The National Foundation for Infectious Diseases (NFID) and the National Consumers League (NCL) are committed to educating people about how to live healthier, safer lives. NFID is focused on educating the public and healthcare professionals about the burden, causes, prevention, diagnosis, and treatment of infectious diseases across the lifespan, and the mission of NCL is to protect and promote social and economic justice for consumers and workers in the United States and abroad.

NFID's Marla receiving her vaccine

NFID’s Marla Dalton receiving her flu vaccine.

Both organizations recognize the tremendous benefits that vaccination provides for both individuals and entire communities. While fall and winter raise the need for annual vaccination against influenza (flu), and the current pandemic has led to the need for COVID-19 vaccines and boosters, we must not overlook the importance of routine vaccines that may have been missed during the pandemic. Vaccines are for people of all ages and there are specific vaccines recommended for children, adolescents, adults, and older adults 65+ to protect against serious and potentially deadly diseases.

NCL and nearly 150 other partner organizations are proud to participate in the NFID Keep Up The Rates campaign, to share messages to encourage all individuals to receive recommended vaccines that may have been delayed during the pandemic. Since the campaign launched in 2020, Keep Up The Rates has engaged national experts and leading public health organizations to reach populations most at risk of delaying vaccinations or experiencing complications from vaccine-preventable diseases.

Sally Greenberg getting vaccinated.

Keep Up The Rates recently released resources to educate healthcare professionals and consumers about vaccine coadministration—receiving multiple vaccines at the same time. When you bring your car in for an oil change, a good mechanic takes care of other routine maintenance to make sure your car runs safely. Protecting your health is not much different, so when you receive a COVID-19 vaccine or a flu vaccine, we encourage you to make sure that you are protected against other serious but preventable diseases. A new PSA and infographics are available to help share that messaging with all relevant audiences.

The COVID-19 pandemic has demonstrated that protecting public health is more important than ever. Just as we must always protect the rights of consumers and workers, we must also encourage measures that promote better health and a safe environment for all.

NCL applauds approval of the pediatric COVID-19 vaccine

November 2, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242

Washington, DC—The National Consumers League (NCL) applauds the coordinated efforts of the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to approve the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11. Consumers should be reassured that an unbiased advisory committee composed of medical and scientific experts have reviewed the data and have held public meetings to provide Americans with a transparent approval process.

“NCL is committed to educating consumers about vaccine safety and efficacy in order to increase vaccine confidence. Every day, parents make tough decisions to keep their children safe. We want parents to feel informed and empowered in their decision to vaccinate their children. As a parent of two boys ages 8 and 10, I’m looking forward to being able to protect my children from COVID-19 and put this pandemic behind us,” said NCL Director of Health Policy Jeanette Contreras.

Parents and guardians are encouraged to use the CDC’s V-Safe mobile app to tell the CDC about any side effects experienced after getting vaccinated. Parents will be able to add dependents to their account and get reminders if you need an additional dose. Register here: https://vsafe.cdc.gov/

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Jeanette Contreras portrait

¿Buscando cobertura médica? Healthcare.gov open enrollment begins November 1

By NCL Director of Health Policy Jeanette Contreras with contributions by NCL Intern Grace Mills

The 2022 open enrollment period for the Health Insurance Marketplace is about to begin! Consumers can enroll in a health plan on Healthcare.gov beginning November 1.

As we commemorate Hispanic Heritage Month, the National Consumers League (NCL) wants Latino consumers to better understand their health coverage options through the Health Insurance Marketplace. Latinos make up approximately 18 percent of the U.S. population and represent the largest minority population (62.1 million). However, it is concerning that 22 percent of non-elderly Latinos are uninsured – the highest uninsured rate of any racial group in the United States.

Under the American Rescue Plan, more consumers are now eligible for increased tax credits that further reduce the cost of monthly premiums. An estimated 69 percent of uninsured Latino adults can access a zero-premium plan and 80 percent can access a plan that costs less than $50 a month. Additionally, consumers can use the Healthcare.gov platform to find out if they or their dependents can qualify for Medicaid or the Children’s Health Insurance Program. Here is what you need to know to make sure that you and your loved ones are insured during 2022.

  • The open enrollment period starts on November 1, 2021, and runs through January 15, 2022. In order for your coverage to start on January 1, you must enroll by December 15, 2021.
  • Your income will determine what you will pay for your health coverage plan.
  • Applications will be accepted online, by calling 1-800-318-2596, or through a certified enrollment partner. Learn more about the different ways to apply.

This year, the Centers for Medicare and Medicaid Services (CMS) has issued $80 million in grants to fund Health Care Navigators across the country that are trained and certified to assist consumers with enrolling in a health plan. While agents and brokers are also available, Navigator Grantees are often a trusted source of information in their communities and can offer culturally competent enrollment assistance. Consumers can find local in-person assistance or an agent/broker in their area by clicking here.

¿Buscando cobertura médica? La inscripción abierta de Cuidadodesalud.gov empieza el 1 de noviembre

¡La inscripción abierta para el Mercado de Seguros Médicos por el año 2022 empezará muy pronto! Los consumidores pueden inscribirse en un plan de salud por medio de CuidadoDeSalud.gov empezando el 1 de noviembre.

Para conmemorar el Mes de la Herencia Hispana, la Liga Nacional de Consumidores (“NCL” por sus siglas en inglés) desea que los consumidores latinos conozcan sus opciones de cobertura de salud a través de los Mercados de Seguros Médicos. Los latinos constituyen el 18% de la población de los Estados Unidos y representan la población de minorías más grande (de 62.1 millones). Sin embargo, nos preocupa que solamente el 22% de los Latinos adultos (que no son mayores) no tienen cobertura de salud y representan la tasa más alta sin seguro médico de todos los grupos raciales en EE. UU.

Bajo el Plan de Rescate Americano (conocido como “American Rescue Plan” en inglés), más consumidores están elegibles por los créditos fiscales que reducen el costo de sus pagos mensuales. Aproximadamente, el 69% de los Latinos (no asegurados} pueden acceder a un plan sin costo alguno y el 80% pueden acceder a un plan que cueste menos de $50 por mes. Además, los consumidores pueden usar la plataforma CuidadoDeSalud.gov para ver si ellos o sus dependientes califican para Medicaid o el Programa de Seguro de Salud Para Niños (conocido como “CHIP” por sus siglas en ingles). Aquí está lo que necesitan saber para que usted y sus seres queridos tengan cobertura médica durante el 2022.

  1. El período de inscripción empieza el 1 de noviembre del 2021 hasta el 15 de enero del 2022. Para tener cobertura empezando el 1 de enero del 2022, necesitas inscribirte para el 15 de diciembre del 2021.
  2. Lo que tú pagarías por un plan de cobertura médica dependerá de tu ingreso anual.
  3. Se aceptarán solicitudes: En-línea, llamando al 1-800-318-2596, o cualquier sitio web de inscripción, que esté certificado. Para obtener más información sobre las diferentes formas de como inscribirse use este enlace: https://www.cuidadodesalud.gov/es/apply-and-enroll/how-to-apply/

Este año, Los Centros de Servicios de Medicare y Medicaid ha dado un subsidio de $80 millones para financiar los navegadores de salud a través del país que están calificados y certificados para ayudar con la inscripción en un plan de salud. Mientras que los agentes y corredores también están disponibles, los navegadores son una fuente de información en las comunidades latinas y ofrecen a sus comunidades asistencia confiada sobre la inscripción. Los consumidores pueden encontrar asistencia en persona o con un agente/corredor en donde viven, usando el enlace: https://ayudalocal.cuidadodesalud.gov/es/#/

NCL offers support for Star Rating for Biosimilars Act, H.R. 2855

October 13, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (724) 799-5392

Washington, DC—The National Consumers League (NCL) is pleased to support the Star Rating for Biosimilars Act, as introduced by Representatives Paul D. Tonko (D-NY) and Bob Gibbs (R-OH). NCL believes that implementing a rating system for biosimilars would incentivize insurers to provide lower cost drug alternatives and alleviate the financial burdens on patients.

The Centers for Medicare and Medicaid Services (CMS) currently has a star ratings system for insurance plans under Medicare Advantage and Part D. The quality measures capture items such as clinical quality, beneficiary satisfaction, patient outcomes, and regulatory compliance. This rating system helps the CMS evaluate which plans to keep and discontinue. To date, we do not have a comparable rating system where biosimilars are concerned. “Biosimilars are on average 30 percent cheaper than their biologic counterparts, yet many existing barriers in our current healthcare plans prevent patients from accessing these cost-saving medicines,” said NCL Director of Health Policy Jeanette Contreras.

The Star Ratings for Biosimilars Act would require the CMS to put in place a five-star performance rating system for biosimilar products under Medicare Advantage Plans. For each plan, the ratings will be based on quality measures meant to evaluate the level of access that each insurance plan provides to biosimilars, such as whether a biosimilar is on the formulary, and the percentage of enrollees prescribed a biosimilar when its biologic counterpart is available. Aside from Advantage Plans, the bill would also require the CMS to incorporate these measures into a similar rating system for plans under the Medicare Part D prescription drug benefit.

The NCL believes in transparency as a core function of informed decision-making. Knowing whether cost saving biosimilars would be available to enrollees under various Medicare (including the Medicare Advantage plans) and Part D plans would bring in more transparency to help consumers be more informed when selecting a plan. “Allowing consumers to see which plans are offering access to lower cost biosimilars would also incentivize Medicare plans to increase patient access to biosimilars,” said Contreras. We encourage Congress to pass the Star Rating for Biosimilars Act in order to broaden access to and encourage increased provision of cost-saving biosimilars.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL supports the Helping Adults Protect Immunity (HAPI) Act

September 30, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242

Washington, DC—The National Consumers League (NCL) is pleased to support the Helping Adults Protect Immunity (HAPI) Act (HR 2170), introduced by Representative Darren Soto (D-FL) in the House and by Senator Sherrod Brown (D-OH) in the Senate. The bill would expand access to immunizations for adults by eliminating cost-sharing for vaccines recommended by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP).

“Throughout its rich history, NCL has advocated for increased access to vaccines as life-saving medical interventions. The HAPI Act is common sense legislation that would help to eliminate out-of-pocket costs for all vaccines recommended by the ACIP,” said NCL Director of Health Policy Jeanette Contreras. This legislation would apply to crucial immunizations such as Shingles and tetanus, diphtheria, and pertussis vaccines, along with future vaccines.

NCL is grateful for the important role of the ACIP to make recommendations using evidence-based research methods, examining the harm-benefit ratio, and understanding the values of the affected populations. Currently, all ACIP and CDC recommended vaccines are covered with no out-of-pocket costs under private insurance, Medicare Part B, and ACA Medicaid Expansion. Unfortunately, traditional Medicaid beneficiaries must often pay varying out-of-pocket costs for recommended vaccines depending on the state.

More than 50,000 adults in the United States die annually from vaccine preventable deaths. The HAPI Act would help to lower that number significantly by providing more vaccine access to Medicaid beneficiaries, our most vulnerable low-income populations. “No one should be unable to obtain a vaccine due to cost barriers. We can ensure that all Americans are protected against preventable diseases regardless of their state of residence or their ability to pay,” said Contreras.

NCL urges Congress to pass the HAPI Act to ensure Medicaid beneficiaries across the country have  equitable access to recommended vaccines across lifespan.

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL stands behind CDC COVID-19 booster recommendations

September 29, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242

Washington, DC—The National Consumers League (NCL) applauds the coordinated efforts of the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to approve the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine booster. As the Delta variant continues to cause more breakthrough cases among vaccinated individuals, it is clear that we need to ensure the protection of our most vulnerable populations.

On September 24, CDC Director Rochelle Walensky went beyond the recommendations of the Advisory Committee on Immunization Practice (ACIP) and made the call to recommend the single-dose booster to frontline workers in addition to those groups recommended by ACIP. Walensky’s recommendations are in line with those of the FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC), which voted to approve the EUA of the booster shot for individuals older than 65 years of age, individuals at high risk for severe disease, and those with institutional or occupational exposure to COVID-19.

“NCL has long advocated for increased access to the vaccine for frontline, essential workers and equitable distribution of the vaccine to populations hardest hit by the pandemic,” said Jeanette Contreras, NCL Director of Health Policy. “The single-dose booster shot is a necessary measure to ensure the safety of those most at risk, and to further mitigate the spread of the COVID-19 virus.” The essential workers who received their Pfizer-BioNTech vaccines early in the pandemic are next in line for the booster shot, recommended at least six months after completion of the primary two-dose series.

“Consumers who were vaccinated with the Moderna or Janssen COVID-19 vaccine are on the edge of their seats,” said Contreras. “In some cases, consumers may want to get a Pfizer-BioNTech booster shot even if they’ve had one of the other vaccines. We want consumers to know that there is still not enough data for the FDA to approve mixing the vaccines.” The Administration has signaled that while recommendations for ‘mixing and matching’ vaccines will come later in October, they are working closely with Moderna and Johnson & Johnson to get their booster shots approved in the coming days.

Consumers who completed the primary series of the Pfizer-BioNTech COVID-19 vaccine, branded as Comirnaty, now have ready access to the booster shot. Consumers must demonstrate they had their second dose of the vaccine at least 6 months ago and attest to being in the approved high-risk population groups. NCL stands behind the recommendations of the CDC and will continue to ensure that consumers have access to life-saving vaccines.

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.